MAUDE Adverse Event Report: K-C AFC MANUFACTURING, S. DE R.L. DE C.V POISE IMPRESSA : PESSARY, VAGINAL : HHW

Model Number	PESSARY
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Non-us event; occurred in canada.Consumer reported that after 8 hours of wearing a pessary, she attempted to remove it and the string separated from it in one piece.She was unable to manually remove the pessary from her vaginal cavity herself so she went to the emergency room where it was successfully removed.She reported experiencing pain during her attempted removal and cramping after it was removed.She has recovered and she did not require any medication.
Additional Manufacturer Narrative
Records demonstrate that quality system procedures were correctly followed, the finished product met all quality release criteria, and specifications were within allowable limits prior to release.Additionally, companion samples received of the product showed no defects or abnormalities.

• Brand Name: POISE IMPRESSA : PESSARY, VAGINAL : HHW
• Common Device Name: PESSARY, VAGINAL
• Manufacturer (Section D): K-C AFC MANUFACTURING, S. DE R.L. DE C.V; calzada industrial de las maquiladoras #87; nuevo nogales; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer (Section G): K-C AFC MANUFACTURING, S. DE R.L. DE C.V; calzada industrial de las maquiladoras #87; nuevo nogales; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 22026324
• Report Number: 3011109575-2025-00023
• Device Sequence Number: 7220222
• Product Code: HHW
• UDI-Device Identifier: 00036000496208
• UDI-Public: (01)00036000496208(17)280501(10)NN420071A
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PESSARY
• Device Lot Number: NN420071A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female